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| Product NDC Code | 72578-086 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Desonide |
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| Type | Generic | ||||||
| Pharm Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| RxCUI drug identifier | 349351 | ||||||
| Application Number | ANDA210198 | ||||||
| Labeler Name | Viona Pharmaceuticals Inc | ||||||
| Packages |
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Overdosage of Desonide
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.OVERDOSAGE Topically applied desonide cream, 0.05% can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.ADVERSE REACTIONS In controlled clinical trials, the total incidence of adverse reactions associated with the use of desonide cream, 0.05% was approximately 1%. These adverse reactions were pruritus, pain, folliculitis, rash, peripheral edema, pustular rash, sweating, erythema, irritation, and burning. Laboratory abnormalities were found in 3% of the patients. These were hyperglycemia (2%) and liver function abnormality (1%). The following additional local adverse reactions have been reported infrequently with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in approximate decreasing order of occurrence: dryness, folliculitis, acneiform eruptions, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, miliaria, burning and hypopigmentation. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY Like other topical corticosteroids, desonide has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2 . Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Studies performed with desonide cream, 0.05% indicate that it is in the low range of potency as compared with other topical corticosteroids.
Pharmacokinetics
Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Studies performed with desonide cream, 0.05% indicate that it is in the low range of potency as compared with other topical corticosteroids.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS Desonide cream, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.DESCRIPTION Desonide cream, 0.05% contains desonide (Pregna-1, 4-diene-3, 20-dione, 11, 21-dihydroxy-16, 17-[(1- methylethylidene)bis(oxy)]-,(11β,16α)) a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primary synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, desonide, the active ingredient in desonide cream, 0.05% is C 24 H 32 O 6 . It has the following structural formula: The molecular weight of desonide is 416.51. It is a white to almost white crystalline powder. It is insoluble in water, soluble in methylene chloride, sparingly soluble in ethanol (96%), slightly soluble in ethyl ether. Each gram of desonide cream, 0.05% contains 0.5 milligram of desonide micro dispersed in a base of aluminum sulfate, calcium acetate, cetostearyl alcohol, dextrin, glycerin, light mineral oil, purified water, sodium lauryl sulfate, synthetic beeswax, and white petrolatum. Desonide cream, 0.05% is preserved with methylparaben and buffered to pH 4.2 to 5.0. Desonide Cream
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DOSAGE AND ADMINISTRATION Desonide cream, 0.05% should be applied to the affected area as a thin film two to four times daily depending on the severity of the condition. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within two weeks, reassessment of diagnosis may be necessary. Desonide cream, 0.05% should not be used with occlusive dressings.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATIONS AND USAGE Desonide cream, 0.05% is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. It should not be used for longer than two weeks unless directed by a physician.
Spl product data elements
Usually a list of ingredients in a drug product.Desonide Desonide DESONIDE DESONIDE ALUMINUM SULFATE CALCIUM ACETATE CETOSTEARYL ALCOHOL GLYCERIN ICODEXTRIN LIGHT MINERAL OIL METHYLPARABEN PETROLATUM SODIUM LAURYL SULFATE WATER YELLOW WAX WHITE TO OFF-WHITE
Laboratory tests
Information on laboratory tests helpful in following the patient’s response to the drug or in identifying possible adverse reactions. If appropriate, information may be provided on such factors as the range of normal and abnormal values expected in the particular situation and the recommended frequency with which tests should be performed before, during, and after therapy.Laboratory Tests The following tests may be helpful in evaluating patients for HPA axis suppression: ACTH stimulation test A.M. plasma cortisol test Urinary free cortisol test
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 72578-086-01 Desonide cream, 0.05% 15 g Rx only Desonide Cream Desonide Cream
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Manufactured by: Zydus Lifesciences Ltd. Changodar, Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc. Cranford, NJ 07016 Rev.: 08/22
Desonide: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.Information for Patients Patients using topical corticosteroids should receive the following information and instructions: This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. This medication should not be used for any disorder other than that for which it was prescribed. The treated skin area should not be bandaged, otherwise covered or wrapped, so as to be occlusive unless directed by the physician. Patients should report to their physician any signs of local adverse reactions.
Nursing mothers
Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when desonide cream, 0.05% is administered to a nursing woman.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.Pediatric Use Safety and effectiveness in pediatric patients have not been established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)Pregnancy Teratogenic Effects Pregnancy Category C Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. Animal reproductive studies have not been conducted with desonide cream, 0.05%. It is also not known whether desonide cream, 0.05% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. There are no adequate and well-controlled studies in pregnant women. Desonide cream, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED Desonide cream, 0.05% is white to off white cream and is available as follows: NDC 72578-086-01 in tube of 15 g NDC 72578-086-02 in tube of 60 g Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Call your doctor for medical advice about side effects. You may report side effects to Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS General Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests. Patients receiving superpotent corticosteroids should not be treated for more than two weeks at a time and only small areas should be treated at any one time due to the increased risk of HPA suppressions. One of ten patients treated for one week under occlusion (30% of body surface) with desonide cream, 0.05% developed HPA axis suppression as determined by metapyrone testing. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products. Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios (see PRECAUTIONS - Pediatric Use ). If irritation develops, desonide cream, 0.05% should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing. If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of desonide cream, 0.05% should be discontinued until the infection has been adequately controlled. Desonide cream, 0.05% should not be used in the presence of infection at the treatment site, hypersensitivity to corticosteroids, or pre-existing skin atrophy. Desonide cream, 0.05% should not be used in the eyes. FOR EXTERNAL USE ONLY. Information for Patients Patients using topical corticosteroids should receive the following information and instructions: This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. This medication should not be used for any disorder other than that for which it was prescribed. The treated skin area should not be bandaged, otherwise covered or wrapped, so as to be occlusive unless directed by the physician. Patients should report to their physician any signs of local adverse reactions. Laboratory Tests The following tests may be helpful in evaluating patients for HPA axis suppression: ACTH stimulation test A.M. plasma cortisol test Urinary free cortisol test Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic, mutagenic, or fertility impairment potential of desonide cream, 0.05%. Pregnancy Teratogenic Effects Pregnancy Category C Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. Animal reproductive studies have not been conducted with desonide cream, 0.05%. It is also not known whether desonide cream, 0.05% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. There are no adequate and well-controlled studies in pregnant women. Desonide cream, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when desonide cream, 0.05% is administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API